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NCT07436533

Osseodensification for Narrow Alveolar Ridge Expansion

Sponsor: University of Science and Technology, Yemen

View on ClinicalTrials.gov

Summary

This prospective, single-arm, non-randomized interventional clinical study was designed to evaluate the immediate horizontal dimensional change in narrow alveolar ridges following osseodensification-assisted dental implant-site preparation. Eligible participants with healed edentulous sites in the maxilla or mandible underwent implant-site preparation using osseodensification burs operated in densifying mode. Alveolar ridge width was measured directly using standardized Micro Castroviejo bone calipers at three predefined levels: the crestal level and 5 mm and 10 mm apical to the crest. Measurements were obtained immediately before and immediately after osseodensification-assisted osteotomy preparation. The primary outcome was the within-site change in alveolar ridge width at the three measurement levels. Additional assessments included insertion torque at implant placement and recorded postoperative complications. The study included a single treatment group and did not include a conventional-drilling or alternative ridge-expansion comparison group

Official title: Expansion of Narrow Alveolar Ridges Using Osseodensification Burs for Dental Implant Placement: A Prospective Single-Arm Interventional Clinical Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-02-01

Completion Date

2026-09-01

Last Updated

2026-08-11

Healthy Volunteers

Yes

Conditions

Osseodensification Bone Expansion Alveolar Bone Loss Jaw, Edentulous, Partially

Interventions

PROCEDURE

Densah burs (Osseodensification Technique)

Dental implant osteotomies were prepared using sequential osseodensification burs operated in counterclockwise densifying mode under copious irrigation. The burs were advanced using a controlled pumping motion according to the study protocol. Ridge width was measured immediately before and after completion of the osteotomy at three predefined levels, followed by dental implant placement and insertion-torque recording.

Inclusion Criteria: * Adults aged 18 years or older and within the upper age limit specified in the final ethics-approved protocol. * Healed edentulous sites involving single or multiple missing teeth in the maxillary or mandibular arches. * A post-extraction healing period of at least 6 months before implant placement. * Adequate vertical bone dimensions for dental implant placement, as assessed using CBCT. * Absence of active local infection or pathological lesions at the proposed implant site. * Clinical suitability for dental implant placement and osseodensification-assisted osteotomy preparation. * Ability and willingness to provide informed consent and attend the scheduled follow-up visits. * Maintenance of acceptable oral hygiene. * Alveolar ridge width of ≤8 mm at the crestal level, measured buccolingually, and considered to require horizontal expansion during implant-site preparation. * Implant sites classified as Misch D1-D4 according to the protocol-specified bone-quality assessment. Exclusion Criteria: * Acute or chronic infection or a pathological condition at the proposed implant site. * Severe buccal plate undercut or ridge concavity that precluded safe implant-site preparation. * Insufficient vertical bone height for the planned dental implant. * Inadequate interarch distance for implant-supported rehabilitation. * Severe parafunctional habits, including clinically significant bruxism or clenching. * Heavy smoking, defined as more than 10 cigarettes per day. * Use of medications considered likely to compromise bone healing according to the approved protocol, including relevant corticosteroid or antiresorptive therapy. * Uncontrolled systemic disease or a medical condition that could materially affect surgical healing or implant treatment. * History of radiotherapy to the head and neck or chemotherapy within the preceding 5 years. * Current pregnancy at the time of the surgical procedure. * Inability or unwillingness to provide informed consent or attend the required follow-up visits

Locations (1)

60 Meters St., Madbah, University of Science and Technology

Sanaa, S, Yemen